FDA product code FSW: Light, Surgical, Endoscopic
FSW is the FDA product code for light, surgical, endoscopic. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under FSW, from 8 different applicants. The average 510(k) review took 77 days (median 79).
Classification
| Field | Value |
|---|---|
| Device name | Light, Surgical, Endoscopic |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FSW clearance
Top FSW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Genzyme Biosurgery | 1 | 2002-11-25 |
| Aculux, Inc. | 1 | 2002-02-01 |
| M.P. Video, Inc. | 1 | 1994-10-17 |
| Cuda Products Co. | 1 | 1993-11-18 |
| Medical Illumination, Inc. | 1 | 1992-09-02 |
3 more applicants have FSW clearances. See the full list in Caduvo.
Most recent FSW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022989 | Genzyme Biosurgery | RADLITE TISSUE RETRACTOR SYSTEM | 2002-11-25 | 77 |
| K013511 | Aculux, Inc. | XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) | 2002-02-01 | 102 |
| K943342 | M.P. Video, Inc. | MEDICAM XENON LIGHT SOURCE | 1994-10-17 | 97 |
| K934337 | Cuda Products Co. | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE | 1993-11-18 | 72 |
| K922279 | Medical Illumination, Inc. | ILLUMINATOR IV MINOR SURGERY LIGHT | 1992-09-02 | 110 |
Recalls for FSW devices
openFDA lists no recalls for product code FSW.
Frequently asked questions
What is FDA product code FSW?
FSW is the FDA product code for light, surgical, endoscopic. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is FSW?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSW?
Across 8 cleared submissions the average was 77 days from receipt to decision (median 79).
Which companies have the most FSW clearances?
Genzyme Biosurgery (1); Aculux, Inc. (1); M.P. Video, Inc. (1); Cuda Products Co. (1); Medical Illumination, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FSW
- Run a recall and safety report across every FSW manufacturer
- Watch product code FSW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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